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Basic Drug Info
Drug Name:Alprazolam
Manufacturer:Actavis Elizabeth LLC
Other Info:



Clinical Trials:


Indications and Usage

Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual (DSM-III-R) diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety.

Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of six months or longer, during which the person has been bothered more days than not by these concerns.

At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or ‘lump in throat’); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or ‘mind going blank’ because of anxiety; trouble falling or staying asleep; irritability).

These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor.Anxiety associated with depression is responsive to alprazolam.Alprazolam tablets are also indicated for the treatment of panic disorder, with or without agoraphobia.Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R criteria for panic disorder (see CLINICAL STUDIES).Panic disorder is an illness characterized by recurrent panic attacks.

The panic attacks, at least initially, are unexpected.

Later in the course of this disturbance certain situations, eg, driving a car or being in a crowded place, may become associated with having a panic attack.

These panic attacks are not triggered by situations in which the person is the focus of others’ attention (as in social phobia).

The diagnosis requires four such attacks within a four week period, or one or more attacks followed by at least a month of persistent fear of having another attack.

The panic attacks must be characterized by at least four of the following symptoms: dyspnea or smothering sensations; dizziness, unsteady feelings, or faintness; palpitations or tachycardia; trembling or shaking; sweating; choking; nausea or abdominal distress; depersonalization or derealization; paresthesias; hot flashes or chills; chest pain or discomfort; fear of dying; fear of going crazy or of doing something uncontrolled.

At least some of the panic attack symptoms must develop suddenly, and the panic attack symptoms must not be attributed to some know organic factors.

Panic disorder is frequently associated with some symptoms of agoraphobia.Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to four months duration for anxiety disorder and four to ten weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to eight months without apparent loss of benefit.

The physician should periodically reassess the usefulness of the drug for the individual patient.
Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Trembling --

Muscle twitch -- The occurrence of a single contraction or a series of contractions of a muscle.

Ache --

Clammy skin --

Xerostomia -- Decreased salivary flow.

Dizziness -- An imprecise term which may refer to a sense of spatial disorientation, motion of the environment, or lightheadedness.

Lightheadedness --

Nausea -- An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.

Diarrhea -- An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight.

PANIC DISORDER 1 --

Dyspnea -- Difficult or labored breathing.

Hot flushes -- A sudden, temporary onset of body warmth, flushing, and sweating (often associated with menopause).

Menopausal hot flushes -- A sudden, temporary sensation of heat predominantly experienced by some women during MENOPAUSE. (Random House Unabridged Dictionary, 2d ed)

Chest Pain -- Pressure, burning, or numbness in the chest.

Contraindications

Alprazolam tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines.

Alprazolam may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in patients with acute narrow angle glaucoma.Alprazolam is contraindicated with ketoconazole and intraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP 3A) (see WARNINGS and PRECAUTIONS-Drug Interactions).
Open Angle Glaucoma -- Glaucoma in which the angle of the anterior chamber is open and the trabecular meshwork does not encroach on the base of the iris.

Angle Closure Glaucoma -- A form of glaucoma in which the intraocular pressure increases because the angle of the anterior chamber is blocked and the aqueous humor cannot drain from the anterior chamber.

Warnings

Certain adverse clinical events, some life-threatening, are a direct consequence of physical dependence to alprazolam.

These include a spectrum of withdrawal symptoms; the most important is seizure (see DRUG ABUSE AND DEPENDENCE).

Even after relatively short-term use at the doses recommended for the treatment of transient anxiety and anxiety disorder (ie, 0.75 to 4 mg per day), there is some risk of dependence.

Spontaneous reporting system data suggest that the risk of dependence and its severity appear to be greater in patients treated with doses greater than 4 mg/day and for long periods (more than 12 weeks).

However, in a controlled postmarketing discontinuation study of panic disorder patients, the duration of treatment (three months compared to six months) had no effect on the ability of patients to taper to zero dose.

In contrast, patients treated with doses of alprazolam greater than 4 mg/day had more difficulty tapering to zero dose than those treated with less than 4 mg/day.The Importance Of Dose And The Risks Of Alprazolam As A Treatment For Panic Disorder: Because the management of panic disorder often requires the use of average daily doses of alprazolam above 4 mg, the risk of dependence among panic disorder patients may be higher than that among those treated for less severe anxiety.

Experience in randomized placebo-controlled discontinuation studies of patients with panic disorder showed a high rate of rebound and withdrawal symptoms in patients treated with alprazolam compared to placebo treated patients.Relapse or return of illness was defined as a return of symptoms characteristic of panic disorder (primarily panic attacks) to levels approximately equal to those seen at baseline before active treatment was initiated.

Rebound refers to a return of symptoms of panic disorder to a level substantially greater in frequency, or more severe in intensity than seen at baseline.

Withdrawal symptoms were identified as those which were generally not characteristic of panic disorder and which occurred for the first time more frequently during discontinuation than at baseline.In a controlled clinical trial in which 63 patients were randomized to alprazolam and where withdrawal symptoms were specifically sought, the following were identified as symptoms of withdrawal: heightened sensory perception, impaired concentration, dysosmia, clouded sensorium, paresthesias, muscle cramps, muscle twitch, diarrhea, blurred vision, appetite decrease and weight loss.

Other symptoms, such as anxiety and insomnia, were frequently seen during discontinuation, but it could not be determined if they were due to return of illness, rebound or withdrawal.In a larger database comprised of both controlled and uncontrolled studies in which 641 patients received alprazolam, discontinuation-emergent symptoms which occurred at a rate of over 5% in patients treated with alprazolam and at a greater rate than the placebo treated group were as follows:DISCONTINUATION-EMERGENT SYMPTOM INCIDENCE Percentage of 641 Alprazolam-Treated Panic Disorder Patients Reporting Events Body System/Event NeurologicGastrointestinal Insomnia29.5Nausea/Vomiting16.5 Light-headedness19.3Diarrhea13.6 Abnormal involuntary movement17.3Decreased salivation10.6 Headache17.0Metabolic-Nutritional Muscular twitching6.9Weight loss13.3 Impaired coordination6.6Decreased appetite12.8 Muscle tone disorders5.9 Weakness5.8Dermatological PsychiatricSweating14.4 Anxiety19.2 Fatigue and Tiredness18.4Cardiovascular Irritability10.5Tachycardia12.2 Cognitive disorder10.3 Memory impairment5.5Special Senses Depression5.1Blurred vision10.0 Confusional state5.0 From the studies cited, it has not been determined whether these symptoms are clearly related to the dose and duration of therapy with alprazolam in patients with panic disorder.In two controlled trials of six to eight weeks duration where the ability of patients to discontinue medication was measured, 71%-93% of alprazolam treated patients tapered completely off therapy compared to 89%-96% of placebo treated patients.

In a controlled postmarketing discontinuation study of panic disorder patients, the duration of treatment (three months compared to six months) had no effect on the ability of patients to taper to zero dose.Seizures attributable to alprazolam were seen after drug discontinuance or dose reduction in 8 of 1980 patients with panic disorder or in patients participating in clinical trials where doses of alprazolam greater than 4 mg/day for over 3 months were permitted.

Five of these cases clearly occurred during abrupt dose reduction, or discontinuation from daily doses of 2 to 10 mg.

Three cases occurred in situations where there was not a clear relationship to abrupt dose reduction or discontinuation.

In one instance, seizure occurred after discontinuation from a single dose of 1 mg after tapering at a rate of 1 mg every three days from 6 mg daily.

In two other instances, the relationship to taper is indeterminate; in both of these cases the patients had been receiving doses of 3 mg daily prior to seizure.

The duration of use in the above 8 cases ranged from 4 to 22 weeks.

There have been occasional voluntary reports of patients developing seizures while apparently tapering gradually from alprazolam.

The risk of seizure seems to be greatest 24-72 hours after discontinuation (see DOSAGE AND ADMINISTRATION for recommended tapering and discontinuation schedule).
Branded Drugs
The following US Branded drugs contain Alprazolam


XANAX XR -- PHARMACIA AND UPJOHN

NIRAVAM -- SCHWARZ PHARMA INC

XANAX -- PHARMACIA AND UPJOHN CO


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